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宫颈管标本质量对采用酶联免疫吸附测定法诊断沙眼衣原体感染的表观患病率的影响。

Impact of endocervical specimen quality on apparent prevalence of Chlamydia trachomatis infections diagnosed using an enzyme-linked immunosorbent assay method.

作者信息

Kellogg J A, Seiple J W, Klinedinst J L, Levisky J S

机构信息

Department of Pathology, York (Pa) Hospital 17405.

出版信息

Arch Pathol Lab Med. 1991 Dec;115(12):1223-7.

PMID:1722665
Abstract

Duplicate endocervical swabs were collected from 1824 patients for detection of Chlamydia trachomatis. Specimen pairs were combined into 400 microL of 0.9% saline solution. After vortexing, a 40-microL sample was smeared and stained with Papanicolaou's method for detection of endocervical and/or metaplastic (E-M) cells. The remaining specimen was tested for C trachomatis antigen with the use of an enzyme-linked immunosorbent assay (ELISA) procedure (Chlamydiazyme, Abbott Laboratories, North Chicago, Ill). Chlamydia trachomatis antigen was detected and confirmed (with the use of a blocking antibody [Abbott Laboratories]) in only 16 (1.7%) of 918 specimens that lacked detectable E-M cells, but it was detected significantly more frequently not only in 88 (13.3%) of 661 specimens that contained detectable E-M cells but also in 32 (13.1%) of 245 specimens that contained too many red blood cells to analyze microscopically. Of the initially positive ELISA results, none of 37 were falsely positive from specimens that contained 11 or more E-M cells, but significantly more (six [27.3%] of 22) were falsely positive from specimens that lacked detectable E-M cells. Variations in specimen quality had a significant impact on the incidence of both true-positive and false-positive ELISA results and could significantly influence understanding of the prevalence of chlamydial infections in women.

摘要

从1824例患者中采集双份宫颈管拭子用于检测沙眼衣原体。将标本对合并到400微升0.9%盐溶液中。涡旋后,取40微升样本涂片,采用巴氏染色法检测宫颈管和/或化生(E-M)细胞。其余标本采用酶联免疫吸附测定(ELISA)方法(衣原体酶,雅培实验室,伊利诺伊州北芝加哥)检测沙眼衣原体抗原。在918份未检测到E-M细胞的标本中,仅16份(1.7%)检测并确认(使用封闭抗体[雅培实验室])到沙眼衣原体抗原,但在661份检测到E-M细胞的标本中,88份(13.3%)检测到该抗原的频率显著更高,在245份红细胞过多无法进行显微镜分析的标本中,32份(13.1%)也检测到该抗原。在最初ELISA结果为阳性的标本中,含有11个或更多E-M细胞的标本中37份均无假阳性,但缺乏可检测到的E-M细胞的标本中假阳性显著更多(22份中有6份[27.3%])。标本质量的差异对ELISA真阳性和假阳性结果的发生率均有显著影响,且可能显著影响对女性衣原体感染患病率的理解。

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Impact of endocervical specimen quality on apparent prevalence of Chlamydia trachomatis infections diagnosed using an enzyme-linked immunosorbent assay method.宫颈管标本质量对采用酶联免疫吸附测定法诊断沙眼衣原体感染的表观患病率的影响。
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